Sr. Product Marketing Manager, Enterprise GTM

$83,000 - $129,700/Yr

Hologic - Newark, DE

Full-time - Mid Level

Newark, DE

Miscellaneous Manufacturing

About the position

The Quality Engineer role at Hologic focuses on ensuring product quality and compliance in the medical device industry. The position involves leading evaluations, investigations, and root cause analyses based on post-market feedback and field complaints. The Quality Engineer will collaborate with cross-functional teams to implement improvements and corrective actions, driving product quality and innovation while enhancing women's health and well-being.

Responsibilities

• Process and evaluate product returns for manufactured and distributed products.
• Design innovative methods and procedures for inspecting, testing, and evaluating product returns.
• Lead moderate to complex risk management, defect investigation, product investigation, and corrective action activities.
• Monitor and provide regular communication on project success factors such as progress, schedule, budget, and resource needs.
• Responsible for assigned department metrics and lead projects to reach departmental goals.
• Improve product reliability and reduce complaint volumes.
• Collaborate with Service, Operations, Marketing, Engineering, Quality, and R&D teams.
• Ensure products meet applicable regulatory and quality standards and customer expectations.
• Perform activities related to analysis of product quality issues, including attending customer sites for investigations.
• Own investigations and present data to cross-functional teams to determine if further action is required.
• Investigate product returns related to customer complaints and provide timely responses.
• Conduct timely analysis of data and develop investigation plans to identify root causes.
• Identify risks associated with complaint events and perform risk calculations.
• Utilize root cause analysis tools for investigations.
• Manage and perform monthly Quality Investigation Review boards, leading and presenting to stakeholders.
• Provide visibility to the status of investigations, CAPAs, and SCARs.

Requirements

• Bachelor's degree in Engineering (mechanical, biomedical, biomechanical, electrical).
• 5+ years of experience in a related environment.
• Experience in FDA regulated industry is beneficial.
• Experience with cleanroom processes is beneficial.
• Excellent computer skills including word processing, spreadsheet programs, and databases.
• Excellent technical writing skills for quality assurance reports and procedures.
• Strong analytical skills including trend and statistical analysis.
• Ability to plan and supervise project execution, keep to timelines, and prioritize resources.
• Ability to troubleshoot and solve technical issues across multiple assays and platforms.
• Ability to analyze data and draw valid scientific conclusions.
• Ability to document technical work and lead investigations in a GMP environment.
• Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP, CIMS, Lean, Root Cause Analysis, TQM, SPC, and Six Sigma.
• Excellent collaboration and interpersonal skills.
• Working knowledge of FDA and ISO regulations governing the Medical Device industry is beneficial.
• Certified Quality Engineer is beneficial.

Nice-to-haves

• Experience in FDA regulated industry.
• Experience with cleanroom processes.
• Certified Quality Engineer.

Benefits

• Competitive salary and annual bonus scheme.
• Comprehensive training upon joining and continued development throughout the career.